Framing the DuPont/ED Nano Risk Framework

09/01/2007

This summer, DuPont and Environmental Defense released their Nano Risk Framework to guide those involved with nanomaterials to assess and document their handling. Why is the voluntary program being criticized?

By Barbara G. Goode

What do a large multinational chemical company and an environmental-advocacy nonprofit have in common? In the case of DuPont and Environmental Defense (ED), it’s the Nano Risk Framework.

The two organizations began working together in 2005, when DuPont’s chairman/CEO and ED’s president co-authored a Wall Street Journal article, entitled “Let’s Get Nanotech Right.” This summer, the partners released a document/booklet that was created with the input of stakeholders in science, industry, and government-some invited and some that volunteered when the draft Framework was offered for public review in February 2007. According to ED’s Scott Walsh, project manager and co-lead on development of the Framework, the partners added about 15 pages to the original plan based on this input.

The thorough, easy-to-use 100-page publication (available for download at www.nanoriskframework.com)-was announced during a press conference on June 21, 2007 (a report of the introduction event is included as the June 21 entry on the Porter Wright Morris and Arthur blog at www.nanolawreport.com). In the blog, ED explained that it first became interested in nanotech because of the potential for environmental and energy applications-and later discovered EH&S concerns. Because ED’s modus operandi is to work with corporate partners to address issues of concern, the agency looked for a partner candidate and found a willing one in DuPont.

Document details

The document states clearly that it is not meant to be a substitute for government regulation or public discussion, but that it hopes its use will inform further dialog. It is designed for use by those manufacturing or using nano-materials and aims to help ensure proper handling of the materials for reduced risk. ED’s Walsh points out that the basic risk equation must include not only suspected hazard, but also exposure to that potential-and that “reasonable worst-case” assumptions are used to fill in for missing data. The Framework describes a systematic process for identifying, quantifying, managing, and reducing potential risks in six steps:

1. Describe material and application: Develop a general description of the nanomaterial and its intended uses;
2. Profile lifecycle(s): Develop three sets of profiles-of the material’s properties, inherent hazards, and associated exposures throughout the material’s lifecycle;
3. Evaluate risks: Identify and characterize the nature, magnitude, and probability of risks; prioritize information gaps in the lifecycle profiles, and determine how to address them;
4. Assess risk management: Evaluate the available options for managing the risks identified in Step 3, and recommend a course of action;
5. Decide, document, and act: Decide whether to continue development, document the decision and its rationale, share appropriate information with internal and external stakeholders, and determine and initiate any necessary further action; and
6. Review and adapt: Through regularly scheduled reviews as well as triggered reviews, update and re-execute the risk evaluation, ensure risk management systems are working as expected, and adapt those systems as necessary.

The document tailors standard risk management approaches to accommodate the current lack of knowledge about nanomaterials by requesting more information as a material progresses from R&D to commercial production.

Implementation and commentary

The document concludes with a 14-page worksheet (an editable version is available online) that helps reviewers track all relevant information, assumptions, and decisions discussed in the rest of the book.

If you click the Case Studies link at www.NanoRiskFramework.com you can find examples of how DuPont applied the framework to three internal projects.

The document has been both praised and criticized. Praise covers the partners’ inclusive process for development of the document, as well as its professionalism, thoroughness, and “groundedness.” Criticism centers generally around the fact that the document is skewed to favor large corporations (such as DuPont) over smaller nanotechnology developers, and that the fears that a voluntary oversight process might lessen the imperative for mandatory regulation

“This document is welcome and is a significant contribution toward the development of responsible nanotechnology,” says safenano.org, a U.K.-based site dedicated to risk control. “We do have some significant issues with, for example, the choice of test protocols that-in our view-overemphasize the need for in-vivo testing and underplays the contribution that in-vitro testing can make, but these are details.”